Diltiazem in the Treatment of Atrial Fibrillation or Atrial Flutter With Rapid Ventricular Rate

Phase 4

Completed

• Conditions: Atrial Fibrillation With Rapid Ventricular Response; Hypotension Drug-Induced
• Interventions: Drug: Calcium pre-treatment; Other: Placebo

• Registration Number: NCT05661942
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

To compare the relative efficacy for calcium pre-treatment in decreasing incidence of drug induced hypotension after diltiazem administration for treatment of AFF with RVR.

Null Hypothesis: There will be no difference between groups in incidence of hypotension after pretreatment with calcium prior to bolus of diltiazem.

Detailed Description

Non-dihydropyridine calcium channel blockers (CCB) are routinely used in the treatment of atrial fibrillation or flutter with rapid ventricular response (AFF with RVR) however, their use can be limited by drug induced hypotension. This drug induced hypotension limits and complicates CCB use in the treatment of AFF with RVR. Calcium pre-treatment with calcium channel blocker administration has been studied extensively with verapamil administration in preventing drug induced hypotension however, similar studies evaluating calcium pretreatment with diltiazem administration in the prevention of drug induced hypotension are limited.

The purpose of our study is to compare the relative efficacy and safety for calcium pretreatment with diltiazem in the treatment of AFF with RVR in preventing drug induced hypotension. This prospective, randomized double-blinded study will evaluate patients who present to the emergency department at Advocate Christ Medical Center (ACMC) with a diagnosis of AFF RVR with ventricular rate greater than or equal to 120 bpm from IRB approval to June 1, 2024. Via simple randomization, patients will be administered Calcium pre-treatment vs control prior to diltiazem administration. Calcium gluconate 1gm or 100 mL of normal saline will be administered as an intravenous infusion over 5 minutes followed by bolus diltiazem 0.25 mg/kg IV push (with a 20mg max) with repeat diltiazem bolus dose after 15 minutes if rate control not achieved 0.35mg/kg IV push. Calcium gluconate will not be administered with repeat doses of diltiazem. Weight-based dosing of diltiazem was most utilized, though some providers may elect to modify based on the clinical scenario. The primary outcome will be the mean difference in systolic blood pressure (SBP) evaluated at 5 and 15 minutes after administration of diltiazem bolus. Secondary outcomes include decrease in heart rate, conversion to sinus rhythm, and adverse effects of medication administered.

Study Timeline

• Study Start: 2022-11-30
• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2022-12-15
• Study First Posted: 2022-12-22
• Status Verified: 2024-11
• Primary Completion: 2024-11-20
• Study Completion: 2024-11-20
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Age > 18 years or older
• Able to provide informed consent
• Primary diagnosis AFF with RVR greater than or equal to 120 bpm

Exclusion Criteria

• Pregnancy defined as a positive urine HCG
• Hemodynamically unstable patients (SBP <90, MAP <65)
• Stated history of systolic heart failure with reduced ejection fraction (<40%) or evidence of acute heart failure or reduced EF (peripheral edema, JVD, pulmonary edema) on clinical exam or bedside echo
• Patients with left ventricular assist device
• Sinus node dysfunction or preexcitation with accessory pathway (known diagnosis of SVT, WPW or sick sinus syndrome. Delta waves or other evidence of accessory pathway on EKG)
• 2nd or 3rd degree atrioventricular block
• Allergy or sensitivity to any study drugs
• Previously enrolled in this trial during a different patient encounter
• Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium pre-treatment	Calcium pre-treatment	Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl
Placebo	Placebo	diluent (NS) vials

Primary Outcome Measures

Name	Time	Method
Mean Difference in SBP	5 and 15 mins	The primary endpoint is the Mean difference in SBP evaluated at 5 and 15 minutes after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem.

Secondary Outcome Measures

Name	Time	Method
Mean change in heart rhythm	5 and 15 mins	Secondary endpoints include mean change heart rhythm at 5 and 15 minutes after administration of diltiazem bolus, mean change heart rate at 5 and 15 minutes after administration of diltiazem bolus, adverse effects due to administration of Calcium gluconate and adverse effects due to administration of Diltiazem infusion.

Trial Locations

Locations (1)

Advocate Christ Medical Center Emergency Department (ACMC ED); 🇺🇸 Oak Lawn, Illinois, United States